# K962557: Genesis II Zirconium  Femoral Component/Profix Zirconium Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Dec 5, 1996 after 157 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
130 later devices descend from it; 6 cite it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Genesis I C/R and LDK Femoral Component: named in the summary without a submission number
- (no number) Profix C/R Femoral Component: named in the summary without a submission number
- (no number) Genesis I C/R Femoral Component: named in the summary without a submission number

## Most influential descendants
- K042515: Smith & Nephew, Inc. High Performance Knee (2005), 118 descendants of its own
- K071071: Crosslinked Polyethylene Articular Inserts (2007), 66 descendants of its own
- K101499: Journey CR Knee System (2010), 45 descendants of its own
- K094050: Itotal CR Knee Replacement System (2010), 41 descendants of its own
- K091014: Journey BCS Knee System (2009), 41 descendants of its own

## Recalls of this device
- Oct 2, 2024 · Class II · Z-0281-2025: Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.

## Indications for use
Genesis II and Profix Knee Systems are indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term resulit. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. Genesis II and Profix Knee Systems are indicated for use only with cement and are single use devices.

Source page: https://510kreport.com/device/K962557
Methodology: https://510kreport.com/methodology